Alkahest, a company that analyzes blood proteins to develop therapies that address neurological disorders including Alzheimer’s disease, is set to be acquired by partner Grifols in a $146 million deal. Grifols (NASDAQ: [[ticker:GRFS]]) announced Tuesday that it is acquiring the shares of privately held Alkahest that it does not already own. Barcelona, Spain-based Grifols says … Continue reading “Grifols Moves Deeper Into Proteome R&D With $146M Deal for Alkahest”
Category: National
FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures
[Updated, 9/8/2020. See below.] A Blueprint Medicines drug for cancers that carry a certain genetic signature has received FDA approval, making it the latest targeted therapy to pass the regulatory bar this year. The late Friday decision for pralsetinib (Gavreto) covers non-small cell lung cancer (NSCLC). The drug was designed to address cancers characterized by fusions … Continue reading “FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures”
Q&A: BIO CEO Michelle McMurray-Heath Outlines Diversity Goals
It would be hard to find a more challenging time for Michelle McMurry-Heath to join the Biotechnology Innovation Organization as its CEO given the COVID-19 pandemic and the protests over racial inequality in the US. But the organization is trying to rise to the occasion on both fronts, with biotech companies pioneering new responses to … Continue reading “Q&A: BIO CEO Michelle McMurray-Heath Outlines Diversity Goals”
AbbVie Strikes Deal for I-Mab Drug With a Potential Edge in CD47 Chase
The cancer protein CD47 is a hot target for drug developers, but it’s not without issues. Antibody drugs that block this protein can also spark anemia. I-Mab designed its antibody to pose less of an anemia risk and AbbVie, seeing an opportunity to catch up to other CD47 contenders and potentially stand apart from them, … Continue reading “AbbVie Strikes Deal for I-Mab Drug With a Potential Edge in CD47 Chase”
Bio Roundup: Pharma M&A, AbbVie’s Cancer Bet, Biofourmis Bucks & More
Labor Day is just around the corner and many people are looking forward to a last chance to celebrate the waning days of summer. But ahead of the holiday weekend, biopharmaceutical companies were hard at work closing deals. Food conglomerate Nestlé is delving deeper into pharmaceuticals with its $2.6 billion deal to acquire Aimmune Therapeutics, … Continue reading “Bio Roundup: Pharma M&A, AbbVie’s Cancer Bet, Biofourmis Bucks & More”
Biofourmis Hauls In $100M to Scale Digital Therapeutics Globally
Biofourmis, a digital therapeutics startup that employs wearable devices and data analytics to help treat patients, has raised $100 million to scale its offerings globally and develop new products that further blur the lines that once clearly separated drugs from medical devices. The new capital, a Series C round of funding, was led by SoftBank … Continue reading “Biofourmis Hauls In $100M to Scale Digital Therapeutics Globally”
Lumen Bioscience Lands $16M to Engineer “Edible” Antibody Drugs
If Lumen Bioscience achieves its goals, patients will be able to take its drugs the same way some people supplement breakfast: a spoonful heaped onto a bowl of cereal or mixed into juice. The startup harnesses spirulina, protein-rich cyanobacteria touted by many health enthusiasts as a “superfood.” Lumen CEO Brian Finrow (pictured above, right) acknowledges … Continue reading “Lumen Bioscience Lands $16M to Engineer “Edible” Antibody Drugs”
New Podcast and Special Report Explore How AI Is Revolutionizing Drug Discovery and Development
Learn what’s fueling San Francisco’s boom in AI, big data, and R&D, explore promising investment and partnership opportunities, and align the latest trends and technologies with your business by listening to our podcast and downloading our special report complementing Xconomy’s recent Xcelerating Life Sciences event. Artificial intelligence, including machine and deep learning, are revolutionizing the … Continue reading “New Podcast and Special Report Explore How AI Is Revolutionizing Drug Discovery and Development”
Reeling From FDA Rejection, Intercept Pharma Slashes Headcount by 25%
[Corrected, 9/2/2020. See below.] Intercept Pharmaceuticals is cutting one-fourth of its workforce, a decision that comes two months after the FDA rejected its drug candidate for the liver disease nonalcoholic steatohepatitis (NASH). Up until the FDA’s rejection of the drug, obeticholic acid (Ocaliva), Intercept (NASDAQ: [[ticker:ICPT]]) had been preparing for a drug launch. In a … Continue reading “Reeling From FDA Rejection, Intercept Pharma Slashes Headcount by 25%”
Gilead Sciences Places $120M Bet on a Jounce Therapeutics Cancer Drug
Gilead Sciences is opening up its checkbook yet again to add another cancer therapy to its pipeline, this time committing $120 million to Jounce Therapeutics for rights to an antibody drug approaching clinical testing. The Jounce (NASDAQ: [[ticker:JNCE]]) drug, JTX-1811, is intended to selectively deplete regulatory T cells—the type of immune cells that suppress the … Continue reading “Gilead Sciences Places $120M Bet on a Jounce Therapeutics Cancer Drug”
Early Bird Sale for Xcelerate at Biotech Week Boston Ends This Friday
Don’t miss out on savings for this year’s online Xcelerate Keynote Series at Biotech Week Boston – our early bird sale ends this Friday! Speakers include: Jeff Baker – Deputy Director, Office of Biotechnology Products, FDA Michelle McMurry-Heath – President & CEO, BIO John Maraganore – CEO, Alnylam Pharmaceuticals Yvonne Greenstreet – Chief Operating Officer, Alnylam Pharmaceuticals Andrew Plump … Continue reading “Early Bird Sale for Xcelerate at Biotech Week Boston Ends This Friday”
Akcea Therapeutics Is Returning to Parent Ionis Pharma in $500M Buyout
[Updated 9/1/2020, 7:58 a.m. See below.] Akcea Therapeutics is returning to its parent company, Ionis Pharmaceuticals, in a $500 million deal that brings an end to a tumultuous three years as a standalone company. The definitive agreement announced Monday calls for Carlsbad, CA-based Ionis (NASDAQ: [[ticker:IONS]]) to pay $18.15 for each share of Akcea (NASDAQ: … Continue reading “Akcea Therapeutics Is Returning to Parent Ionis Pharma in $500M Buyout”
Nestlé to Swallow Up Peanut Allergy Drug Maker Aimmune in $2.6B Deal
Aimmune Therapeutics, which this year won the first FDA approval for a food allergy immunotherapy, is set to be acquired by a division of global food giant Nestlé in a deal that values the biopharmaceutical company at $2.6 billion. According to deal terms announced Monday, Nestlé will pay $34.50 for each Aimmune share that it … Continue reading “Nestlé to Swallow Up Peanut Allergy Drug Maker Aimmune in $2.6B Deal”
Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More
Among the casualties of the COVID-19 pandemic: the credibility of government agencies entrusted with protecting public health. The FDA this week granted emergency use authorization for convalescent plasma as a treatment for infection by the novel coronavirus. FDA Commissioner Stephen Hahn and Department of Health and Human Services Secretary Alez Azar both misrepresented the magnitude … Continue reading “Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More”
Athira Aims for the Nasdaq to Advance Alzheimer’s Drug to Phase 2 Tests
Many of the drugs tested in Alzheimer’s disease so far, and some still in development, aim to block or break up proteins associated with the progression of the memory-robbing disorder. Athira Pharma is taking a different approach—neuron regeneration. And it’s doing so by a tapping a protein first discovered in the liver. Seattle-based Athira has … Continue reading “Athira Aims for the Nasdaq to Advance Alzheimer’s Drug to Phase 2 Tests”
AbbVie & UroGen Overactive Bladder Treatment Misses in Phase 2 Trial
A formulation of AbbVie’s blockbuster wrinkle treatment, acquired through its buyout of Allergan, has failed a mid-stage trial as a potential fix for overactive bladder and urinary incontinence. The FDA in 2013 approved the use of onabotulinumtoxinA (Botox) via injection into the bladder as a treatment for overactive bladder in adults who can’t take or … Continue reading “AbbVie & UroGen Overactive Bladder Treatment Misses in Phase 2 Trial”
National Xconomy Awards Digital Ceremony Complimentary Tickets Now Available
On Thursday, Sept. 24 during an free online ceremony, Xconomy will celebrate and announce the 2020 National Xconomy Awards winners – the best in biotech. Leading up to the ceremony, we have designed a complimentary two-week, 11-part, on-demand Meet the Finalists daily webcast series to provide you an opportunity to get to know each of the 44 individuals and … Continue reading “National Xconomy Awards Digital Ceremony Complimentary Tickets Now Available”
Kinnate Raises $98M for Human Tests of Targeted Cancer Therapies
Drugs designed to precisely target cancers with specific genetic signatures have changed the course of disease for many patients. But for the majority, such drugs either don’t work because of innate resistance or they eventually stop working once the cancer develops new mutations that hamper their effectiveness. Kinnate Biopharma, one of the biotechs working to … Continue reading “Kinnate Raises $98M for Human Tests of Targeted Cancer Therapies”
Freenome Tacks on $270M to Advance Blood Tests to Find Cancer Early
The ability to detect early signs of cancer in a patient’s blood could improve prognoses by helping doctors treat the disease before symptoms arise. Freenome, one of the companies racing to commercialize the first such screening test, on Wednesday announced it raised $270 million—money it plans to accelerate a clinical study of an experimental screening … Continue reading “Freenome Tacks on $270M to Advance Blood Tests to Find Cancer Early”
Dyne Eyes IPO for R&D of Genetic Medicines for Rare Muscle Diseases
Not long ago, having early data about how an experimental drug worked in humans was expected of biotechs considering IPOs. Dyne Therapeutics may not reach human testing until 2022, but, like many of its preclinical peers this year, the company is choosing to jump into public markets now while investor interest in the biotech sector … Continue reading “Dyne Eyes IPO for R&D of Genetic Medicines for Rare Muscle Diseases”
Acadia Pharma Acquires CerSci, Potential Pain Meds in $52.5M Buyout
Acadia Pharmaceuticals has acquired Texas biotech CerSci Therapeutics, a privately held company with a clinical-stage molecule under evaluation as a potential therapy for post-surgical and nerve pain. The San Diego-based company splashed out $52.5 million on the buyout, a cash-and-stock deal—$47.2 million of it in Acadia shares, according to a regulatory filing—that closed Monday. Acadia … Continue reading “Acadia Pharma Acquires CerSci, Potential Pain Meds in $52.5M Buyout”
FDA Rejects Tricida Chronic Kidney Disease Drug, More Data Needed
Tricida’s bid for speedy approval of a drug for a condition caused by chronic kidney disease has been rejected by the FDA, which is asking for data that may require conducting another clinical trial. The South San Francisco-based biotech had tested its drug, veverimer, in a Phase 3 study and a follow-on extension study, both … Continue reading “FDA Rejects Tricida Chronic Kidney Disease Drug, More Data Needed”
FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines
The FDA has authorized the use of plasma from people who have recovered from infection by the novel coronavirus as a treatment for hospitalized COVID-19 patients, a move widely perceived as influenced by political pressure given the lack of clear evidence of clinical benefit. Treating patients with plasma—the water, salts, and proteins that make up … Continue reading “FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines”
Yumanity to Merge With Proteostasis to Advance Neuro Drug Pipeline
Yumanity is combining operations with Proteostasis Therapeutics, a deal that gives the biotech a public listing for its neurodegenerative disorder compounds including a Parkinson’s disease drug candidate in early-stage clinical development. According to terms of the merger agreement announced Monday, Proteostasis (NASDAQ: [[ticker:PTI]]) will acquire all outstanding shares of Yumanity in exchange for new shares … Continue reading “Yumanity to Merge With Proteostasis to Advance Neuro Drug Pipeline”
Astellas Reports Third Patient Death in Audentes Gene Therapy Study
A third patient who received an experimental Audentes gene therapy for a rare neuromuscular disorder has died, a disclosure that comes two months after the deaths of two patients led the FDA to place a clinical hold on the study. San Francisco-based Audentes, a subsidiary of Japanese pharmaceutical company Astellas Pharma, said Friday that early … Continue reading “Astellas Reports Third Patient Death in Audentes Gene Therapy Study”
Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More
While business is historically slow in August, this month seems to be bucking the trend, just like so many other unexpected developments in 2020. Perhaps life sciences executives have been less distracted by summer excursions this year in a world in which the COVID-19 pandemic has significantly curtailed travel. This week two pharmaceutical companies announced … Continue reading “Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More”
Harmony Bio and Inhibrx Raise Combined $247M in Public Market Debuts
Two biotechs this week topped the $100 million mark in their respective initial public offerings, both of which were able to offer more shares than planned. One, a company with nearly nine month’s-worth of revenue from a newly commercialized drug and the other, an early-clinical stage oncology drug developer, illustrate the range of biotech companies … Continue reading “Harmony Bio and Inhibrx Raise Combined $247M in Public Market Debuts”
Alzheon Lands $47M to Take Another Shot at a Pivotal Alzheimer’s Test
[Corrected 6:36 p.m. See below.] Alzheon, an Alzheimer’s disease drug developer that has twice filed and withdrawn its IPO plans, now has a $47 million commitment from the National Institutes of Health (NIH) to fund a pivotal study testing an experimental treatment in patients with the memory-robbing disorder. The cash, a five-year grant from the … Continue reading “Alzheon Lands $47M to Take Another Shot at a Pivotal Alzheimer’s Test”
FDA Rejects BioMarin Hemophilia Gene Therapy, Asks for More Data
A gene therapy designed to treat the severest cases of the most common type of hemophilia has been rejected by the FDA, which wants more data on the durability of the investigational treatment developed by BioMarin Pharmaceutical. Letters issued by the FDA turning down experimental treatments aren’t made public, but BioMarin (NASDAQ: [[ticker:BMRN]]) says the … Continue reading “FDA Rejects BioMarin Hemophilia Gene Therapy, Asks for More Data”
J&J Boosts Autoimmune Disease Drug Pipeline With $6.5B Momenta Buyout
[Updated, 7:40 p.m. See below.] Johnson & Johnson is acquiring Momenta Pharmaceuticals in a $6.5 billion deal that brings the pharma giant a slate of experimental autoimmune disease therapies, including a potential blockbuster antibody drug in late-stage development for a rare type of anemia. Momenta (NASDAQ: [[ticker:MNTA]]) develops treatments for diseases driven by autoantibodies—antibodies produced … Continue reading “J&J Boosts Autoimmune Disease Drug Pipeline With $6.5B Momenta Buyout”
Patient Death in Poseida Prostate Cancer Study Prompts Clinical Hold
A Phase 1 trial testing a Poseida Therapeutics cell therapy in men with prostate cancer is on hold after a patient enrolled in the study died of liver failure nearly three weeks after receiving the treatment. The San Diego company, which has touted its product candidates as safer than early-generation versions developed by other companies, … Continue reading “Patient Death in Poseida Prostate Cancer Study Prompts Clinical Hold”
Unity Biotech Arthritis Drug Flunks Phase 2, Spelling Program’s End
Unity Biotechnology’s ambition to develop drugs that treat diseases of aging has failed its first test as its lead candidate, an osteoarthritis treatment, could not beat a placebo in a mid-stage clinical trial. South San Francisco-based Unity (NASDAQ: [[ticker:UBX]]) is developing drugs that remove senescent cells, which are cells that have stopped dividing but still … Continue reading “Unity Biotech Arthritis Drug Flunks Phase 2, Spelling Program’s End”
Genentech Gets FDA OK for Injectable Rare Neuroimmune Disease Drug
A drug that can be administered at home to treat a rare central nervous system disorder that damages the optic nerves and spinal cord now has FDA approval, marking the third nod the agency has given to a therapy for the condition. The drug, satralizumab (Enspryng), from Roche’s South San Francisco-based subsidiary Genentech, is for … Continue reading “Genentech Gets FDA OK for Injectable Rare Neuroimmune Disease Drug”
Tango Therapeutics Adds $175M, Deal Turns Partner Gilead Into Investor
Cancer drug developer Tango Therapeutics is adding $175 million more to its coffers in cash and equity, funds the company says will help it get its lead program into the clinic in 18 months. The money includes $50 million in equity financing, $20 million of that from Gilead Sciences (NASDAQ: [[ticker:GILD]]), plus another $125 million … Continue reading “Tango Therapeutics Adds $175M, Deal Turns Partner Gilead Into Investor”
Bristol Myers Squibb to Splash Out $475M on Dragonfly Immunotherapy
Bristol Myers Squibb is paying nearly half a billion dollars in up front and near-term payments to license an early-stage immunotherapy developed by Dragonfly Therapeutics, a firm that’s already a partner on potential treatments in oncology and other disease areas. New York-based Bristol (NYSE: [[ticker:BMY]]), which inherited a relationship with the biotech when it acquired … Continue reading “Bristol Myers Squibb to Splash Out $475M on Dragonfly Immunotherapy”
Sanofi Reaches $3.68B Deal to Buy Principia and Partnered MS Drug
[Updated, 4:36 p.m.] Sanofi, which has worked with Principia Biopharma for the past three years to develop a new multiple sclerosis treatment that penetrates into the brain, is set to buy its partner in a $3.68 billion deal to advance the development of that drug and other autoimmune compounds in the pipeline. Under financial terms … Continue reading “Sanofi Reaches $3.68B Deal to Buy Principia and Partnered MS Drug”
Advisory Body Backs MesoBlast Therapy for Transplant Complication
An FDA advisory committee Thursday voted 9-1 to recommend that the agency approve a stem cell therapy developed by MesoBlast as a treatment for acute graft-versus-host disease (aGVHD) in children. The panel weighed the need for a new way to address the potentially fatal condition against shortcomings of the clinical trial the Australian biotech conducted … Continue reading “Advisory Body Backs MesoBlast Therapy for Transplant Complication”
CureVac’s IPO Hauls In $213M as Key mRNA COVID-19 Vaccine Test Nears
CureVac is playing catch-up to its messenger RNA (mRNA) peers in the race to develop a COVID-19 vaccine, but the company contends its technology could offer dosing advantages, and it now has $213 million in IPO cash to fund the human tests that could support that claim. On Friday, CureVac (NASDAQ: [[ticker:CVAC]]) sold more than … Continue reading “CureVac’s IPO Hauls In $213M as Key mRNA COVID-19 Vaccine Test Nears”
Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More
The road of drug development is rife with detours and disappointments but Seres Therapeutics showed this week that course corrections can work. Four years after its microbiome therapy failed in a mid-stage study, the company reported early positive data from a pivotal test of its treatment for a type of gut infection. The results are … Continue reading “Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More”
With FDA Nod, NS Pharma Duchenne Drug Becomes Sarepta Competitor
[Updated 8/13/2020, 3:19 p.m.] Duchenne muscular dystrophy (DMD) patients whose disease is characterized by a particular genetic mutation now have a new treatment option following the FDA’s Wednesday approval of a drug developed by NS Pharma. DMD is a genetic disorder that leaves patients unable to produce dystrophin, a protein key to muscle function. NS … Continue reading “With FDA Nod, NS Pharma Duchenne Drug Becomes Sarepta Competitor”
Perceptive Advisors’ LianBio Inks Deals With BridgeBio, MyoKardia
Two California biotechs have teamed up with LianBio, a new company launched earlier this week by hedge fund Perceptive Advisors, as part of deals that expand their reach into China as partners of the fledgling Shanghai-based firm. LianBio is getting the rights to develop and commercialize in Asia certain drugs from the pipelines of Brisbane, … Continue reading “Perceptive Advisors’ LianBio Inks Deals With BridgeBio, MyoKardia”
F2G Lands $60M for a New Tack on Taking Out Rare Fungal Infections
Fungal infections might not immediately come to mind as rare diseases, but growing resistance to older drugs means that patients who develop these infections have limited treatment options. Biotech company F2G aims to give these patients another choice. As the startup looks ahead to late-stage testing of its lead drug candidate, it has raised $60.8 … Continue reading “F2G Lands $60M for a New Tack on Taking Out Rare Fungal Infections”
Pfizer’s Bourla: There’s Coronavirus Vaccine Pressure, But It’s Not Political
Pfizer Inc. CEO Albert Bourla said he doesn’t worry about political pressure to bring potentially the first coronavirus vaccine to market, but can’t escape feeling the weight of the world on his shoulders. Bourla’s company is among the leaders in developing a vaccine that could ease the strain of the global pandemic that has caused … Continue reading “Pfizer’s Bourla: There’s Coronavirus Vaccine Pressure, But It’s Not Political”
Ligand to Spend $438M to Add Protein Maker Pfenex to Technology Lineup
Ligand Pharmaceuticals plans to acquire recombinant protein therapeutics maker Pfenex for $438 million, the companies announced Monday. The larger company agreed to pay $12 per share for Pfenex (NYSE American: [[ticker:PFNX]])—a 57 percent premium to its closing price Monday. San Diego-based Ligand (NASDAQ: [[ticker:LGND]]) generates revenue from licensing deals and royalties paid by pharmaceutical companies … Continue reading “Ligand to Spend $438M to Add Protein Maker Pfenex to Technology Lineup”
Bayer Boosts Women’s Health Drug Pipeline, Paying $425M for KaNDy
Bayer has been building up its women’s health drug pipeline by striking deals and on Tuesday the pharmaceutical giant unveiled its latest one: $425 million up front for KaNDy Therapeutics, a biotech whose experimental menopause drug is projected as a blockbuster seller. KaNDy’s small molecule drug, NT-814, is in development as a treatment for common … Continue reading “Bayer Boosts Women’s Health Drug Pipeline, Paying $425M for KaNDy”
Roche Gut Disease Drug Produces Mixed Results in Late-Stage Trials
Results from four studies within a major Roche-run clinical trials program of an investigational gut disease drug have muddled the antibody’s path forward after its performance proved mixed. The company has been studying etrolizumab, an antibody designed to block two members of a family of proteins called integrins, as a potential treatment for the two … Continue reading “Roche Gut Disease Drug Produces Mixed Results in Late-Stage Trials”
Seres Sets Sights on FDA After C. Diff Microbiome Therapy Scores in Phase 3
[Updated 12:37 p.m.] An experimental Seres Therapeutics capsule of live bacteria has met the goals of a pivotal study evaluating it as a treatment for a type of recurrent gut infection, preliminary results the company says put it on track for an FDA submission—potentially the first-ever application for a microbiome therapy. Seres (NASDAQ: [[ticker:MCRB]]) reported … Continue reading “Seres Sets Sights on FDA After C. Diff Microbiome Therapy Scores in Phase 3”
FDA Green-Lights Roche Spinal Muscular Atrophy Drug, First Oral Therapy
The FDA on Friday approved a new spinal muscular atrophy drug that patients can take at home. Risdiplam (Evrysdi) is a liquid medicine intended for daily use that was developed by Roche subsidiary Genentech in partnership with the SMA Foundation and South Plainfield, NJ-based PTC Therapeutics (NASDAQ: [[ticker:PTCT]]). Regulators OK’d the drug, intended for daily … Continue reading “FDA Green-Lights Roche Spinal Muscular Atrophy Drug, First Oral Therapy”
AbbVie Exits Editas Alliance, Pruning Another Genetic Medicines Pact
AbbVie has terminated a research partnership with Editas Medicines, returning to the biotech rights to an experimental gene-editing treatment. It’s the second genetic medicines alliance the pharmaceutical company exited this week. The Editas therapy, EDIT-101, is in Phase 1 testing as a treatment for a rare, inherited form of blindness called Leber congenital amaurosis type … Continue reading “AbbVie Exits Editas Alliance, Pruning Another Genetic Medicines Pact”
Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More
The novel coronavirus has driven the pharmaceutical industry to upend its research priorities. Big Pharma companies are focusing on vaccine development and a slew of biotechs are testing compounds, previously intended for a wide range of indications, as potential COVID-19 treatments. This week saw another major development brought on by industry efforts to adjust to … Continue reading “Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More”